emergent biosolutions inc (EBS) Key Developments

Emergent BioSolutions, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Anthrasil has received Orphan Drug designation and as a result of this approval, the product qualifies for seven years of market exclusivity. Anthrasil is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis, the bacteria that causes anthrax disease. It is prepared using plasma collected from healthy, screened donors who have been immunized with Emergent's BioThrax® (Anthrax Vaccine Adsorbed) vaccine, the only FDA-licensed vaccine for the prevention of anthrax disease. In support of the U.S. government stockpiling strategy for AIGIV, Emergent continues to perform under a $63 million BARDA contract awarded in 2013 for the collection and storage of anti-anthrax human plasma. This plasma is necessary for the potential future manufacture of bulk drug substance and AIGIV final drug product.

Emergent BioSolutions, Inc. Wins $31 Million Contract for Advanced Development of NuThraxTM

Mar 24 15

Emergent BioSolutions, Inc. announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of NuThraxTM (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company's next generation anthrax vaccine candidate. The contract, valued at $31 million, consists of a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease. Activities to be completed under the contract include process validation, consistency lot manufacture, assay validation, non-clinical studies, and start-up activities in preparation for the Phase 3 clinical trial. This contract HHSO100201500004C for the advanced development of NuThrax is funded by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS). The Phase 2 clinical trial was conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS under development contract number HHSN272201000035C. Contract HHSN272201400038C to develop a dry formulation of NuThrax is also administered through NIAID.

Emergent BioSolutions Inc. announced that, under several agreements signed with the University of Oxford, GSK, and the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) respectively, it has manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) anticipated for use in a Phase 1 clinical study to be conducted by Professor Adrian Hill of the Jenner Institute. This clinical trial is being supported by a grant from the Wellcome Trust and the UK Department for International Development. The study, which will be conducted in the UK, will evaluate the safety of MVA EBOZ as a heterologous boost to GSK's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate. Data from an Ebola vaccine human clinical trial published recently in the New England Journal of Medicine suggest the use of an MVA vector as a potential option to boost the levels of ChAd-primed antibody and T-cell responses. Under these agreements, Emergent performed proof of concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line, which had previously been licensed to the company. Manufacturing in this cell line has significant advantages including removing the requirement for eggs from the manufacturing process, consistency of manufactured vaccine lots, and increases in doses delivered. Manufacturing of the first clinical lot of the MVA EBOZ vaccine candidate is now complete and is undergoing acceptability and release testing. The scalable process has the potential to meet the demand for multi-million doses in a few months. Emergent manufactured the MVA EBOZ vaccine candidate at its Bayview Campus, Baltimore, Maryland manufacturing facility, which is equipped with disposable manufacturing technology such as single use bioreactors that enable production of viral and non-viral products with a quick turnaround. In this facility, Emergent has successfully manufactured product candidates for the company's pipeline, including MVA based vaccines. This facility has also been designated by the U.S. Department of Health and Human Services as a Center for Innovation in Advanced Development and Manufacturing (CIADM) that helps facilitate advanced development and surge manufacturing of medical countermeasures to address public health threats.

Morphosys AG and Emergent BioSolutions, Inc. announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the companies' co-development and commercialization agreement, the achievement of this milestone triggers a payment of USD 5 million by MorphoSys to Emergent. MOR209/ES414 is an immunotherapeutic protein developed by Emergent using its proprietary ADAPTIRTM (modular protein technology) platform. Preclinical in vitro and in vivo studies have shown MOR209/ES414 redirects T-cell
cytotoxicity towards cells expressing prostate specific membrane antigen (PSMA), an antigen commonly found on prostate cancer cells. The study will be conducted in two stages. The primary objective of stage 1 is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously, with weekly dosing for three months and bi-weekly thereafter, to patients with mCRPC. The secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. Within stage 2, the primary objective is to evaluate clinical activity in patients that have or have not received prior chemotherapy, while secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414. This open-label phase 1 clinical study will be conducted in the U.S. and Australia, with a planned enrollment of up to 130 patients.

Emergent BioSolutions Inc. announced unaudited consolidated earnings results for fourth quarter and full year ended Dec. 31, 2014. For the quarter, the company reported total revenues of $147,975,000, income from operations of $44,620,000, income before provision for income taxes of $44,308,000, net income attributable to company of $30,116,000 or $0.66 per diluted share, adjusted EBITDA of $57.5 million, adjusted net income of $34.6 million or $0.75 per diluted share, compared to the total revenues of $98,107,000, income from operations of $23,293,000, income before provision for income taxes of $23,658,000, net income attributable to company of $15,222,000 or $0.41 per diluted share, adjusted EBITDA of $30.8 million, adjusted net income of $17 million or $0.45 per diluted share, for the same quarter a year ago.
For the year, the company reported total revenues of $450,138,000, income from operations of $58,056,000, income before provision for income taxes of $53,062,000, net income attributable to company of $36,741,000 or $0.88 per diluted share, net cash provided by operating activities of $112,318,000, purchases of property, plant and equipment of $30,673,000, adjusted EBITDA of $105.9 million, adjusted net income of $54.2 million or $1.18 per diluted share, compared to the total revenues of $312,745,000, income from operations of $42,802,000, income before provision for income taxes of $43,367,000, net income attributable to company of $31,135,000 or $0.85 per diluted share, net cash provided by operating activities of $96,968,000, purchases of property, plant and equipment of $42,021,000, adjusted EBITDA of $70.6 million, adjusted net income of $37.7 million or $1.03 per diluted share, for the previous year.
The company suspends guidance for 2015. Beginning on January 28, 2015, during standard quality inspections performed in accordance with customary procedures, the company discovered foreign particles in a limited number of vials in two manufactured lots of BioThrax. In order to determine the source of the foreign particles, the company has been investigating its operations as well as those of its suppliers and contract manufacturers. Under the company's quality standards, these two BioThrax lots will be rejected. Currently, there is no evidence that any other BioThrax lots have been affected, but as a precautionary measure, the company has quarantined 13 additional lots in inventory pending the findings of its investigation. It is the company's goal to complete this investigation within the next 60 days. Consequently, no BioThrax deliveries will be made in the first quarter. Based upon current information and depending on the disposition of the quarantined lots, the impact on previously forecasted 2015 BioThrax revenues is anticipated to be between $0 and $65 million. This ongoing investigation does not impact any of the company's other products or manufacturing operations, including the company's Building 55 operations and plans for licensure. Furthermore, there is no current evidence that product in distribution is impacted. Since the investigation is ongoing and the full scope of the issue has not been determined with certainty, the actual impact may be greater than anticipated. As the company is unable to definitively assess the impact to 2015 financial results, it is suspending previously issued 2015 guidance. Guidance will be forthcoming following completion of the ongoing investigation.

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